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Lupus Clinical Trials

New Medical Therapies™

Hearing Impairment

July 2, 2012

Auris Medical issued results from a phase IIb trial of AM-101 for the treatment of acute inner ear tinnitus. The double blind, randomized, placebo-controlled, parallel-dose study enrolled 248 patients whose tinnitus was triggered by acute acoustic trauma, sudden deafness or otitis media. Subjects received three intratympanic injections of AM-101 0.27mg/ml or 0.81mg/ml, or placebo, over three consecutive days. Subjects with acute tinnitus with established cochlear origin who received AM-101 0.81mg/ml showed a statistically significant improvement (p<0.05 or <0.01) in tinnitus loudness, annoyance as well as tinnitus-related sleep difficulties and activity and participation limitations (TBF-12 questionnaire). At day 90, average reductions from baseline levels exceeded 50% for subjective loudness, annoyance and sleep difficulties and close to 50% for the TBF-12 score. Efficacy outcomes in subjects with tinnitus related to ISSNHL were not conclusive for that subgroup overall, owing to an unexpectedly large rate of spontaneous recovery. The most common adverse events were related to the procedure of intratympanic injection. Based on these data, Auris Medical is now in discussion with regulatory agencies on the design for the planned phase III studies.

October 24, 2011

Auris Medical issued results from a phase IIb trial of AM-101 for the treatment of acute inner ear tinnitus. This double blind, randomized, placebo-controlled, parallel dose group trial enrolled 248 subjects with persistent inner ear tinnitus following a documented acute acoustic trauma or sudden deafness incident less than three months before. The subjects received three intratympanic injections of either AM-101 at 0.27 or 0.81 mg/ml or placebo over three consecutive days. The primary endpoint was the change in the tinnitus minimum masking level from baseline to day 90. The subjects who received AM-101 at 0.81 mg/ml showed a statistically significant reduction in tinnitus loudness, sleep impact and the THI-12 questionnaire score (p<0.05 or <0.01). Local treatment with AM-101 was well tolerated, and had no negative impact on hearing.

October 3, 2011

Otonomy issued results from a phase Ib trial of OTO-104 for Meniere's disease. This randomized, placebo-controlled, multicenter study enrolled 44 subjects with unilateral Meniere's disease. The subjects received OTO-104 (3mg or 12mg) or placebo administered as a single intratympanic injection. During a one month baseline period, the subjects experienced an average of eight days with definitive vertigo episodes. Following a single intratympanic injection, subjects in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, the 12 mg study group experienced a 70% greater reduction from baseline in the number of days with definitive vertigo episodes. In addition, both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus. This improvement was seen as early as one month following treatment and continued throughout the entire three month follow-up period.

May 9, 2011

Otonomy reported results from a phase Ib trial of OTO-104 for Meniere's disease. This randomized, double-blind, placebo-controlled trial enrolled 44 subjects. Following a one-month baseline period to characterize disease status, the subjects received a single intratympanic injection of OTO-104 (3mg or 12mg) or placebo. OTO-104 was well-tolerated at both doses. Data also showed that subjects receiving OTO-104 experienced greater reductions in vertigo frequency and tinnitus compared to those receiving placebo.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.